Identity
- Trade Name
- K-ASSAY® Lp(a) Control FDA UDI
- Generic Name
- Total lipoprotein IVD, control FDA UDI
- Device Name
- For use as a consistent test sample of known concentration for monitoring assay conditions for lipoprotein(a) [Lp(a)]. FDA UDI
- Model / Reference
- K114C-4M FDA UDI
- Description
- For use as a consistent test sample of known concentration for monitoring assay conditions for lipoprotein(a) [Lp(a)]. FDA UDI
Identifiers
- Catalog Number
- K114C-4M FDA UDI
- Primary DI / UDI-DI
- 00816426020979 FDA UDI
- 510(k) Number
- K023853 FDA UDI
- FDA Product Code
- DFC FDA UDI
- GMDN Term
- Total lipoprotein IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5600 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Total lipoprotein IVD, control
K-ASSAY® Lp(a) Control by Kamiya Biomedical Company, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total lipoprotein IVD, control.
- Drew Scientific — Drew Scientific , Ltd. · Class II
- Drew Scientific — Drew Scientific , Ltd. · Class II
- Drew Scientific — Drew Scientific , Ltd. · Class II
- Drew Scientific — Drew Scientific , Ltd. · Class II
- Drew Scientific — Drew Scientific , Ltd. · Class II
- Drew Scientific — Drew Scientific , Ltd. · Class II
- Lipoprint LDL Subfractions Kit 4x25 tests — QUANTIMETRIX CORP. · Class I
- Drew Scientific — Drew Scientific , Ltd. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kamiya Biomedical Company, Llc
Sources (1)
- FDA UDI c29e435a-9b57-49f0-a993-515ee73a143e 37 fields · synced May 30, 2026